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ÒAdaptive Pathways for Personalised Medicines Ð Supporting Innovation in EuropeÓ

3 December 2013 - London

2nd Edition, A workshop hosted by EBE in collaboration with European Medicines Agency and the Italian EmbassyÕs Scientific Office in London

Venue: Italian Cultural Institute, 39 Belgrave Square, London SW1X 8NX

This yearÕs EBE hosted regulatory policy workshop entitled ÒAdaptive Pathways for Personalised MedicinesÓ is aiming to highlight the important approaches to Personalised Medicines, the related progress in science and the need for development, regulatory and public health pathways to adapt. In preparation for the Italian EU Presidency 2014, this policy workshop will allow biopharmaceutical industry and key stakeholders to shed light on the future of Omics and how Personalised Medicines can be made available and provide the best value for Patients.

10.00-10.30 Keynote address:

Guido Rasi, EMA (confirmed) and DG Sanco 10.30-12.00

New opportunities for personalised medicines research in public health:

What has personalised medicines (PM) delivered so far and what is the experience in the public health research setting? What are the academic expectations and what role can SMEs play?

PANELISTS

Michel Goldman, Innovative Medicines Initiative Ð Moderator (confirmed) Michelangelo Campanella (invited)

Tom Lillie, Amgen, Chair of EBE Personalised Medicines Task Force (confirmed) Helga RŸbsamen-Schaeff, AiCuris (confirmed)

Iain Miller, General Electrics (confirmed) 12.00-13.00 Lunch

13.00 -14.30

How can we reinforce support to Personalised medicines in Europe:

How can regulatory pathways adapt to new science and what is the role of big data and its impact on development and regulatory activities? How can research and development be fostered in Europe, how is it funded and what role does institutional platforms play?

PANELISTS

Marisa Papaluca, EMA Ð Moderator (confirmed) Irene Nordstedt, DG Research (confirmed) EBE Company Representative (invited) Ingrid Klingman, EFGCP (invited) Richard Barker, CASMI (confirmed) Andrea Ponti, JP Morgan (confirmed) 14.30-15.00 Break

15.00 - 16.30

Factors affecting uptake of personalised medicines by European healthcare systems

How do you measure the impact in healthcare systems and value of the medicines? What role do companion diagnostics play and how can early patient access, adaptive pricing & flexible reimbursement models support the realisation of the full value of innovation? What incentives reward innovation and how can smaller patient populations support innovation? What lessons have been learnt from personalised and orphan medicines in bringing solutions to patients?

PANELISTS

Luca Pani, AIFA Ð moderator (confirmed) Carole Longson, NICE (confirmed) DG Enterprise (invited)

Vinciane Pirard, Genzyme (confirmed) Spiros Vamvakas, EMA (confirmed) 16.30-16.45 Closing note:

Roberto Gradnik, President EBE and Sergio Pecorelli, President AIFA (confirmed)

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ACCESS TO THE VENUE:

Italian Cultural Institute, 39 Belgrave Square, London SW1X 8NX, tel +44 (0) 20 7235 1461

Transports:

- Closest tube stops:

o At Kings Cross St. Pancras take the Piccadilly Line and leave the train at Hyde Park Corner.

Journey: Kings Cross St. Pancras -> Russell Square -> Holborn -> Covent Garden -> Leicester Square -> Piccadilly Circus -> Green Park -> Hyde Park Corner (Piccadilly line, 6 min walk) o Victoria (Victoria, District and Circle lines, located inside Victoria Station, 14 min walk) - Bus:

o 52 (from Victoria Station, alight at Hyde Park Corner stop, 3 min walk) o 73 (from Victoria bus station, alight at Hyde Park Corner stop, 3 min walk) - Railways:

o Victoria Station (closest, 15 min walk)

o St Pancras IntÕl Ð TGV terminal (Piccadilly line to Hyde Park Corner, 15 min) - Public transports from airports:

o Heathrow: Piccadilly line (any terminal, alight at Hyde Park Corner, 48 min) o London City: DLR + Jubilee line + Piccadilly line (34 min)

o Gatwick: train to Victoria Station (30 min, every 15 min)

o Stansted: National Express bus to Victoria Station (~ 75 min, every 15 min) or train to Liverpool Street Station (45 min, every 15 min) + tube to Hyde Park Corner (21 min)

ORGANISING COMMITTEE:

EBE EMA Italian Embassy Scientific Office

Titta Rosvall-Puplett Marisa Papaluca and Melanie Carr Salvator Roberto Amendolia Titta.Rosvallpuplett@ebe-

biopharma.org

[email protected] / [email protected]

[email protected] Tel: +32 472 55 94 87 Tel: +44 2074 188 575 Tel: +44 7733 367 007

Attendance to the workshop requires registration, which can be done via this Online Registration link until 25 November.

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